China National Biotec Group Company Limited
This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above
COVID-19 Pneumonia
COVID-19
SARS-CoV-2 Vaccine (Vero Cell), Inactivated
Phase 3
This is a open label clinical trial to evaluate the efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines (Vero cell) developed by Beijing Institute of Biological Products Co., Ltd in healthy people aged 3-17 years old in comparison with healthy population aged 18 years old and above. Total of 1800 healthy volunteers aged 3 years old and above will be enrolled, of whom the subjects will be divided into two groups, 3-17 years old group and 18 years old and above group with each consisting of 900 volunteers. The 3-17 years old group was further divided into three subgroups: 3-6 years old, 7-12 years old and 13-17 years old, with 300 volunteers in each subgroup. 2 doses of vaccines will be injected into the deltoid muscle of either upper arm according to the immunization schedule of D0, D21 (+7 Days). Based on interim analysis'results of the booster dose administered to adults aged 18 years old and above, a booster dose might be introduced.}}
Study Type : | Interventional |
Estimated Enrollment : | 1800 participants |
Masking : | None (Open Label) |
Primary Purpose : | Prevention |
Official Title : | Immunogenicity Non-inferiority Immuno-bridging Study of Inactivated SARS-CoV-2 Vaccine in Healthy Population Aged 3-17 Years Old vs Healthy Population Aged 18 Years Old and Above |
Actual Study Start Date : | July 2, 2021 |
Estimated Primary Completion Date : | March 31, 2022 |
Estimated Study Completion Date : | April 29, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Aged 3-6 years old 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced. |
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated |
Experimental: Aged 7-12 years old 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced. |
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated |
Experimental: Aged 13-17 years old 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced. |
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated |
Active Comparator: Aged ≥18 years old 300 subjects receive 2 dose according to the immunization schedule of D0, D21 (+7 Days). A booster dose might be introduced. |
Biological: SARS-CoV-2 Vaccine (Vero Cell), Inactivated |
Ages Eligible for Study: | 3 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Sheikh Khalifa Medical City, SEHA
Abu Dhabi, United Arab Emirates, 51900